FDA Dietary Supplement Regulation

Quality Smart Solutions ensures your labels meet DSHEA and 21 CFR code of federal regulations. We review your labels, advise on structure-function claims, prepare a substantiation dossier (if required) and file a pre-market notification with FDA . We guide you to market your products, and stay compliant with FDA regulations.

Overview of Dietary Supplements

Dietary supplements are health and wellness products that contain dietary ingredients, including minerals, vitamins, herbs, amino acids, botanicals, and other categories of ingredients that can be used to supplement diets. The forms of dietary supplements include but are not limited to tablets, powders, capsules, gummies and liquids. The supplements are used to improve health, used for prevention of ailments and and for the maintenance of overall wellness.

Based on the CRN Consumer Survey on Dietary Supplements conducted in 2019, 77% of Americans consume dietary supplements. The majority of both are males and females, aged 18+ years. Among the age groups, adults between the ages of 35 – 54 years share 18% consumption, the highest usage of dietary supplements. Consequently, the nutritional supplement industry is witnessing massive growth, primarily in vitamins and protein supplements.

FDA Dietary Supplement Regulatory Requirements

FDA governs Dietary Supplements. FTC governs the marketing and advertisement of dietary supplements. Failure to comply with the regulations can result in FDA warning letter issuance, FTC fines, stop sale, recall and potential litigation. If you exporting dietary supplements to the United States it may result in entry refusal and the U.S. Customs and Border Protection detaining your goods. As a manufacturer, importer, or distributor of dietary supplements and dietary ingredients, you’re solely responsible for assessing the safety and labeling of your products. You must ensure products adhere to all the requirements of FDA and DSHEA regulations. Here are a list of requirements to keep in mind for your dietary supplement.

Labeling Requirements

You must follow the labeling requirements, such as nutrition labeling, ingredient labeling, and nutrient content, health claims, dietary supplement packaging regulations, etc.

Supplement Facts Panel

Having a ‘Supplement Facts Panel’ is mandatory for every dietary supplement to be marketed in USA. The panel must have all information required by FDA.

Notification to FDA

According to Federal Food, Drug, and Cosmetic Act, FDA must be notified within 30 days of your dietary supplement first marketed in USA.

Health Claims

FDA and FTC require health claims about the safety of your dietary supplements that must be supported with reliable scientific evidence.

Some of our Clients We Have Helped Ensure FDA Compliance

Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with FDA

5 Star Google Reviews

Shams W.Pawel Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael MT Consulting

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Donal Gauvreau Sapro

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!

Types of Dietary Supplement Labels We Have Reviewed

We have reviewed a wide range of Dietary Supplement Product Labels, including but not limited to the following.

Sports Nutrition

Greens

Probiotics

Multi Vitamins

Nootropics

Beauty Enhancers

Aromatherapy

Anti-Oxidants

Traditional Medicine

Gummies

End to End Solutions for Dietary Supplements in USA

Our team consists of professionals who have extensive FDA Dietary Supplement, Food, Pharma, Medical Device, and Drug regulatory, licensing experience having reviewed over 1500 dietary supplement labels.

Dietary Supplement Label Review

Our US regulatory specialists will review your label, Supplement Facts Panel (SFP), Structure-function claims, and give suggestions to meet labeling requirements and ensure SFP is in the correct format

Supplement Facts Panel Creation

Our officers will assist you in creating Supplement Facts Panel with adequate attention to box, font, thickness, etc., and ensure it strictly adheres to the required format and remain print-ready.

Health Claims Substantiation Dossier

We will empower you to prepare dossiers for supporting the efficacy and safety of your dietary ingredients according to the standards of evidence as described in the Federal Act.

Structure-Function Claims pre-market Notification

Do not worry about structure-function claim notification as our specialists will assist you in preparing the structure-function claim notification and submitting it through mail or electronically.

Dietary Supplement Foreign Facility U.S. Agent Service

We cater to all criteria required to serve as a US agent. With expert knowledge and extensive experience, we are able to answer every question the FDA may have in case of an emergency.

Dietary Supplement Facility Registration and Renewal

Our US Regulatory experts will help you register or renew your food or dietary supplement facility with FDA. We make the entire registration and renewal process simple and cost-effective

New Dietary Ingredient Notification (NDIN)

We determine if your ingredient is a New Dietary Ingredient, prepare a full dossier for a New Dietary Ingredient Notification, request for FDA pre-submission meeting, and address any questions asked by the FDA.

Prior Notice FDA Clearance

If you are shipping dietary supplements into the United States a Prior Notice must be filed prior to arrival. An FDA confirmation with a bar code must accompany most dietary supplements at port of entry.

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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